Home Applications 217221 Application 217221
Type ANDA
Sponsor DIFGEN PHARMS Application Products# Product, Drug, Ingredient table Product Drug Ingredient Form Strength Reference drug Reference standard 001 LIDOCAINE LIDOCAINE PATCH;TOPICAL 1.8% No No
Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A217221-001 LIDOCAINE LIDOCAINE 1.8% PATCH / TOPICAL AB 2025-03-25
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A217221-001 AB
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 A217221-001 LIDOCAINE 1.8% PATCH / TOPICAL AB 2025-03-25 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A217221-001 LIDOCAINE 1.8% PATCH / TOPICAL AB 2025-03-25 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A217221-001 LIDOCAINE 1.8% PATCH / TOPICAL AB 2025-03-25 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A217221-001 LIDOCAINE 1.8% PATCH / TOPICAL AB 2025-03-25 6a471c1ec25d…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A217221-001 LIDOCAINE 1.8% PATCH / TOPICAL AB 2025-03-25 a50c72e98297…
Observed Orange Book normalized TE history# openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 7 of 26 · 515 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Lidocaine LIDOCAINE YYBA Corp 472fe0d1-31a1-fded-e063-6394a90a4a66 2026-03-25 Warnings Name fallback brand name: Lidocaine generic name: LIDOCAINE EjaGuard LIDOCAINE MOLANSPACE INC 475f64ef-d636-7e87-e063-6294a90ae32f 2026-03-25 Warnings Name fallback generic name: LIDOCAINE LIDOCAINE LIDOCAINE YYBA Corp 4db609cc-f329-62a4-e063-6394a90aefc1 2026-03-23 Warnings Name fallback brand name: LIDOCAINE generic name: LIDOCAINE LIDOCAINE LIDOCAINE DIRECT RX a575bcb8-478f-1f7e-e053-2995a90a4b12 2026-03-17 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE generic name: LIDOCAINE Lidocaine LIDOCAINE Direct_Rx 00725e5b-694c-b9e1-e063-6294a90a4182 2026-03-17 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Lidocaine LIDOCAINE Direct_rx 29f211ff-dcba-afb0-e063-6294a90afb9b 2026-03-17 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE Crane Safety Burn LIDOCAINE Crane Safety LLC 96d81566-6321-731e-e053-2995a90ad07d 2026-03-16 Warnings Name fallback generic name: LIDOCAINE LIDOCAINE LIDOCAINE DIRECT RX b8663046-67a4-4858-e053-2a95a90a8aed 2026-03-16 Warnings, Adverse reactions Name fallback brand name: LIDOCAINE generic name: LIDOCAINE Lidocaine LIDOCAINE Asclemed USA, Inc. e0bfe16f-7a3f-48e0-a2e6-2ec68159a888 2026-03-14 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE CVS Pain-Relieving LIDOCAINE CVS Pharmacy 4cd3a3fb-d59c-92a5-e063-6294a90a1737 2026-03-12 Warnings Name fallback generic name: LIDOCAINE lidocaine LIDOCAINE A-S Medication Solutions 967b0c5d-679d-4b69-9d6a-bc322baf6e04 2026-03-10 Warnings, Adverse reactions Name fallback brand name: lidocaine generic name: LIDOCAINE Lidocaine Cream, 4% LIDOCAINE IPG PHARMACEUTICALS, INC. 7775bfdd-7eac-4f09-b83f-fc4a16a24558 2026-03-10 Warnings Name fallback generic name: LIDOCAINE Careland Lidocaine Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. 7de99b81-b3b3-49f1-8aa7-2ff42e1b46a4 2026-03-09 Warnings Name fallback generic name: LIDOCAINE Welmate Lidocaine Pain Relieving Patch LIDOCAINE YYBA Corp cff71b75-fc4e-29ac-e053-2995a90abd50 2026-03-06 Warnings Name fallback generic name: LIDOCAINE Careland Pain Relief Patch Plus LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. d55d8a9e-ed2b-4c9b-9ecb-6ec1fd43c9e3 2026-03-04 Warnings Name fallback generic name: LIDOCAINE Numb Fast Hemorrhoidal LIDOCAINE Oasis Plus LLC a00ffed7-8034-4cc0-87c4-3c793c1bcd6e 2026-03-03 Warnings Name fallback generic name: LIDOCAINE Equate Hemorrhoid Relief LIDOCAINE Walmart Inc. 48646860-ed5d-62a0-e063-6394a90abb23 2026-03-01 Warnings Name fallback generic name: LIDOCAINE NUMBING CREAMS LIDOCAINE Yongchun Lihui Trading Co., Ltd. 3b5e1a74-5946-4f1f-e063-6394a90a404b 2026-02-27 Warnings Name fallback generic name: LIDOCAINE Maximum Strength 4% Lidocaine Patch Good Neighbor Pharmacy LIDOCAINE InterMed Laboratories Private Limited 4bade8a9-43bd-b649-e063-6294a90a81da 2026-02-25 Warnings Name fallback generic name: LIDOCAINE Lidocaine LIDOCAINE Sportpharm LLC 1112681c-8de7-472b-8db4-2702054b835b 2026-02-23 Warnings, Adverse reactions Name fallback brand name: Lidocaine generic name: LIDOCAINE